ANDA 77356, held by Meitheal. Mitoxantrone Hydrochloride.
As of Nov 15, 2026, ANDA 77356 (Mitoxantrone Hydrochloride), held by Meitheal, was first approved by FDA on Apr 11, 2006, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Mitoxantrone injection, USP (concentrate) is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). Mitoxantrone injection, USP (concentrate) is not indicated in the treatment of patients with primary progressive multiple sclerosis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 11, 2006 | Original application | Approved |
| Mitoxantrone HydrochlorideEQ 20MG BASE/10ML (EQ 2MG BASE/ML) · injectable;injection | Mitoxantrone Hydrochloride | Rx |
| Mitoxantrone HydrochlorideEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) · injectable;injection | Mitoxantrone Hydrochloride | Rx |
| Mitoxantrone HydrochlorideEQ 30MG BASE/15ML (EQ 2MG BASE/ML) · injectable;injection | Mitoxantrone Hydrochloride | Rx |
| Dec 5, 2012 | Supplement 20Labeling · Standard review | Approved | None posted |
| Nov 14, 2012 | Supplement 16Labeling | Approved | None posted |
| Nov 12, 2009 | Supplement 4Labeling | Approved | None posted |
| Apr 11, 2006 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
